Characteristic Ximelagatran (N = 982) Warfarin (N = 967) Type of surgery*

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TH E JO U R N A LO F BO N E & JO I N T SU R G E R Y · J B J S.O R G VO L U M E 87-A · NU M B E R 10 · OC T O B E R 2005

XI M E L A G A T R A N CO M P A R E DW I T H WA R F A R I NF O R PR E V E N T I O N O F TH R O M B O E M B O L I S M AF T E R TO T A L KN E E AR T H R O P L A S T Y

Electronic Appendix The EXULT B Study Group

The members of the EXULT B Study Group are as follows: Ex- ecutive Committee: Charles W. Francis (cochair), University of Rochester Medical Center, Rochester, New York; Clifford W.

Colwell Jr. (cochair), Scripps Clinic, La Jolla, California; Philip C. Comp, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma; Jeffrey S. Ginsberg, McMaster Uni- versity, Hamilton, Ontario, Canada; Jay R. Lieberman, UCLA Medical Center, Los Angeles, California; Guy Paiement, San Francisco General Hospital, San Francisco, California; Scott D.

Berkowitz, AstraZeneca LP, Wilmington, Delaware; Jennifer McElhattan, AstraZeneca LP, Wilmington, Delaware; Anne W.

Roth, AstraZeneca LP, Wilmington, Delaware; and Seva Pan- filov, AstraZeneca R&D, Mölndal, Sweden. Data Safety Moni- toring Board: Robin S. Roberts (chair), Hamilton Civic Hospitals Research Center, Hamilton, Ontario, Canada; Mar- vin Steinberg, Hospital of the University of Pennsylvania, Phila- delphia, Pennsylvania; and Alexander G.G. Turpie, Hamilton Health Sciences Corporation, Hamilton, Ontario, Canada. In- dependent Central Adjudication Committee: Michael Gent (chair), Jack Hirsh, Clive Kearon, Mark Levine, and Jeffrey Weitz, McMaster University, Hamilton, Ontario, Canada.

Site Investigators and Coordinators

The following institutions and persons participated in the study (principal investigators are indicated by an asterisk, and the pre- vious principal investigator for the clinical site is denoted by a dagger symbol): United States: Arizona — J.A. Dupont,* R.

Korn; Arkansas — W.F. Hefley, Jr.,* W.S. Bowen, K.A. Martin, M. Alexander, S. Marti, K. Mills, K. Mercer, P. Short, L. Hast- ings, R. Satre, K. Weaver, D. Jacks; California — G.W. Bradley,*

S.A. Plunkett, S.M. Ford, S. Braverman, J. Wrench, L. Harter, D.

Fox; C.W. Colwell, Jr.,* S.N. Copp, M. Saeed, K. Ezzet; S.T. Gh- erini,* S. Croopnick, D. Wentworth, B. Fellmeth, C. DeLemos;

H. Kim,* H. Jergeson, R. Sawhney, S. Wall, K. Stanley, A. Sabal- vara-Torres; R. Mudiyam,* D. Tapadiya, G.S. Patel, M. Soroudi;

L. Kwong,* S. Slaugher-Markman, P. Ballesteros, B. Morrow, S.A. Mikulak, J. Harvey, D. Feingold, M. Hewitt, R. Larson, J.

Ballesteros, B. Wiley; C. Libanati,* P. Reiswig, G. Watkins, A.

Gustafson, D. Wallace, K. Anderson, S. Closson, K. Jolley, N.

Hamada, O. Hohmann, T.K. Donaldson, A. Firek, D. Barnes, M.

Patel; W. Navigato,* M.T. Mai, R.P. Sakover, D.D. Kim, N.J. Hal- bridge, J.B. Gonzalez, S.P. Suzuki; T. Miclau,* G.D. Paiement,†

A. Davidson, E. Ring, H. Kim; D.R. Shah,* J. Stockwell, J.C.

Kim, M. Shah,* K.M. Cirimelli; G. Vallier,* C. Caporiccio, L.

Tocchi, M.C. Garcia, R. Burky, Jr., K. Shimansky, M. Schneider, D. Smith; R. White,* D. Link, B. Bowman, J. Rodrigo, J. Mee- han, M. Wilde, J. Robbins; M.P. Kimball,* A. Sauer, H.J. Ander- son, R.A. Sauer; L. Walker,* W. Navigato, M. Soroudi, J.H.

Block; Colorado — P.N. Lammens,* K. Carlton, D. Hunter, J.

Guyon; J.D. Papilion,* R.L. Greenberg, J.P. Lindberg, H.A.

Motz, F.K. Yamamoto, T. Nash, R. Allen, J. Ferrari, D. Chang;

Connecticut — C. Lewis,* S.F. Schutzer, J.C. Grady-Benson, G.A. Zimmerman, W.J. Glucksman, M. Pederson; Florida — D.G. Bramlet,* L.M. Gnage, R.G. Hamilton, B.R. Bolhofner,

R.L. Swiggett, Jr., C.B. Davis II, M.J. Smith, J.A. Rodriguez Jr., W.E. Lowry, B.D. Burke, G.H. Canizares, R.P. Nantais, B.D.

Fishalow, C.A. Finn, D.A. Rubins, J.D. Stone, G.A. Call, J.M. Va- lone, V.C. Page, B.J. Klug, N.M. Farone, T. McTigue, N.P.

Lausch, F.T. Wilkins, A.A. Sharf, K.R. Kirn, C.M.C. Ruiz; O.F.

Cannon, Jr.,* R.J. Brill, T.D. Lowell, T.E. Lafferty, J.E. Fletcher, K.L. Hisey, J.H. Huddleston, R.E. Prieto, J.R. Locker, N. Burch, A.E. Mattheus, V.B. King, M.C. Standley, S.A. Vining, M.P.

French; K. Duane, L.P. Bitting, H.J. Smith, III, M.S. Farber; S.I.

Hakki,* S. Harwood, J. Hoeldtke, V. Bilotta, S. Coleman, J. Jen- kins; S. Augustine,* L. Derting, J. McAdams, B. Yearty, J. Ollie, D. Darracott, P. Baumann, D. Siragusa, H.M. Northrup, J. Vu;

G.S. Kantor,* K. Vaughn, N. Joyce, R. Sarner, W.P. Roemer; M.J.

Koren,* S. Neims Greco, J.A. Jacqmein, R.O. Pohl, Jr., D.M.

Helmsworth, F.W. Sanchez, D.M. Robison, S.J. Lancaster, D.A.

Whitaker, F.A. Hakim; L. Mead,* S.S. Brady, B.L. Woodard, C.E.

Stahl, K. Lee-Sinkler, J. Polen, G. Rego, S. Lagman; H.B. Mor- ris,* K.A. Krumins, J.B. Billings, J.F. Byrnes, Jr., R.C. Prati; H.

Schuele,* W.A. Hughes, J. Kilgore, C. Abrahamsen, M. Ben- jamin, F. Persechino; R. Strain, Jr.,* A.J. Reich, W. Grossman, S.D. Steinlauf, M. Kravitz, J. Blaze; W.K. Furman,* D.M Karp, W.R. Kennedy III, E.J.G. Kennedy, D.A. Sugar, D.J. Slevin, R.J.

Lichtenstein, F.M. Tow, F.T. Wilkins, A.A. Sharf, C.M.C. Ruiz, N.P. Lausch, T. Finan, V.C. Page, B.J. Klug, H.W. Vogler, C.A.

Diaz, C.W. Rush, G.S. Sharpiro, K.R. Kirn, N.M. Farone, J.R.

Ayers, R.A. Smith, Sr.; Idaho — C.E. Poole,* D. McGee, N.C.

Femino, J.A. Thomason, B. Nelson; Illinois — G. Allan,* D.J.

Olysav, T. Renfree, L. Klingler, W. Payne, C.M. Bearss, W.

Moore; Iowa — J. Kimelman,* M. Flapan, M. Matthes, R.E.

Johnson, M.S. Rosenfeld, T. Kenney, S. Meyer, S. Misol, W.C.

Young, L. Kiley; Kentucky — F.A. Burke,* H. Lockstadt, J.K. Far- ris, G.L. D’Angelo, N. Ellingsen, V.A. Vaslcek, J. Balthrop, T.D.

Cervoni, K. Schlenther, D. Winebrenner, E.S. Wilhite, E. Harris, P.M. Brown, C. Riley; A.A. Yashar,* A. Tapp, E.E. Jacob, P. Lin- ville, J. Sunderland, T. Ramey; B.A. Wittmer,* J.M. Donley, J.E.

Mesa, S.L. Davis, G.M. Garrett, J. Young, T. Furgerson, J. Esser, B. Holder, C.M. Pinkerton; Louisiana — E.J. Lisecki,* D.A. Ber- nard, H.J. Hebert, Jr., J.O. Landry, B. Snellgrove, T.T. Landry, P.

Davis; Maryland — D.F. Dalury,* K. Groh, M.J. Adams, L.F.

Kiniry, D. Faison; K. Larson,* R.K. Chung, J.J. McLaughlin;

Montana — D.L. Woolley,* P.B. Peterson, M. Stewart; New Jer- sey — A. Pagliaro,* T.J. Capotosta, Jr., D.J. Fletcher, K.

McGuigan, K. Banglawala, R. Agri, C. Terry, K.L. Kunkle, M.J.

Levine, G. Tusay, A. Meyers, J.R. Schnell, W. Gomez, R.J. Col- lins, P.J. O’Donnell, P. Holtzman, M.S. Bursack; New York — C.W. Francis,* S.A. Bean, A.D. Boyd, Jr., K.L. Kaplan, E. Spreng, J.M. Shults, D.L. Waldman; H.F. Riegler,* J.D. Marquardt, M.P.

Neracker, D.B. Wopperer, J.A. Schuster; I. Ziv,* J. Haumesser, C.

Meinking, J. Mikulsky, K. Ammerman, E. Sattelberg, M. Cook;

North Carolina — T. McCoy,* J.B. Mason, R.B. McBride, Jr., T.H. Buter, W.G. Moorefield, Jr., W.L. Griffin, M. Ohl, A.L.

Rhyne, III, P.P. Gilbert, T. Fehring, B.V. Darden, II, M.H. Long, A. Smidowicz, J. High, H.Y. Dunaway, III, J.S. Gaul, III, J. Jester, D. DuPuy, A. Guirgues, P. Capecci, R. Fields, B. Arnold, D.S.

Uri, D. Ballard-Wright, N. Summers, K. Prassas, J. Beaghan, J.E.

Foster, S.R. Cooklish, K.R. Crump, T.D. Thomas, D.M. Banit,

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TH E JO U R N A LO F BO N E & JO I N T SU R G E R Y · J B J S.O R G VO L U M E 87-A · NU M B E R 10 · OC T O B E R 2005

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M.A. Dobzyniak, M. Talbert; Ohio — J. Rusin,* A.S. Kaufman, B. Martin, B. Connolly; R.L. Kalb,* G.P. Rothhaas, B.A. Martin, M.A. Ramsey, M.S. Wheeler, A.S. Kaufman, T.L. Wheeler, M.M.

Razook, S.A. Williams, D.A. Coreasel, K.A. McConnaughy;

W.B. Stanfield,* M.S. Mooney, E. Martinez, L. Allegretto; Okla- homa — Phillip C. Comp,* S.W. Farriester, C.W. Beam, D. Al- exander, F.E. Rabe, K.R. Robinson; Oregon — K.C. Buehler,*

D.A. Rogers, S.R. Tyler, R.L. Thomas, T. Clautice-Engle, D. Sils- bee, C. Nix; Pennsylvania — B.E. Gunnlaugson,* J.M. Moses, I.

Katz, D.A. Lowry, V.E. Vena, R.D. Schroeder, P.J. Ridella, K.

Betcher, D.H. LeHew, M. Buday, O. Cooley, S. Kaselar, J. Burda, P. Wolfe, P. Lorditch; P.A. Lotke,* J.P. Garino, C. Nelson, W.

Ritchie; South Carolina — R.J. Friedman,* M. DeVito, D.J.

Skinner; Texas — Roger H. Emerson, Jr.,* J.M. Hillyard, R.D.

Reitman, L. Higgins, M. Jenson, N. Alexander, T. Wen; G.S.

Gill,* C. Dihenia, A. Romero, T. Hegstrom, J. Stark; P.C. Peters, Jr.,* G.E. Maale, M.J. Champine, M.M. Katz, W. Dittman, L.

Smith; J. Seaquist,* C. Bales, T. Fletcher, C. Craig, M.V. Hill, K.M. Cusick; S.J. Siff,* M. Skolkin, J. Wade, G. Landon; D.L.

Fox,* R.E. Wilcox, P.L. Kujawa, K.W. Rohweder, B.E. Schulze, S.L. Sledge, M. Froman, A. Book, S. Sykes; Virginia — M.W.

Wolfe,* S.C. Mull,† P.P. Jones, P.L. Standifer, R.F. O’Brien, B.A.

Bradshaw, A.J. Manville, D.J. Novak, B.A. Torre, B. Spetzler, A.N. Hicks, M.S. Smith, A.A. Durham, L. Richey, J.A. Porter, C.L. Guth, S. Harrell, W.C. Atkinson; Washington — W.L. Lan- zer,* T. Allen, S.R. Parlkh, G.S. Ferguson, K.J. Randall; Canada:

Alberta — M.J. Mant,* L.M. Larratt, D.B. Russell, A.R. Turner, D. Au, J.G. Cinats, D.W.C. Johnston, P.A. Donahue, P. Kochan- ski, L. Haykowsky, G.H. Woolsey, M.A. Hamilton, M.V. Lavoie;

L.K. Bredo,* R. Perlau, W.R. Reikie, T. Pearce, D. Danciulescu, S.

Danciulescu, A. Poole, B. Capusten, Y. Bos, L. Humbke, C. Cun- dal, J. Glen; British Columbia — L. Vickars,* P. Galbraith, S.

Horlick, D. Werry, J. Barberie, C. Li, G. McKenzie, W. Yu, H.

Hawk, K. Stothers, P. Harrison, P. Chipperfield; W. Pisesky,*

D. Boyce, G. O’Connor, T. O’Farrell, J. Oliver, G. Kindrachuk, S. Krywulak; P. McAllister,* C. Landells, M. Stanger, D. Lawer- ence, S. Southerland; C. Cameron,* W. Malone, B. Woodruff, P. Gutmanis, F. Kernachan, J. Bonnell, P. Trepamier; Manitoba

— V. deKorompay,* J.E. Irving, S. Ulrich, D. Balageorge, G.W.

Pierce, S. Stewart; New Brunswick — S. Dolan,* B. Archer, S.

Connolly, K. Crane, T. Cambell; Ontario — P. Wells,* Melissa Forgie, R. LaRose, P. Murnaghan, J. Aquino, M. Rodger*, J.

Brunet, G. Dervin, P. Kim, K. Cernohorsky, R. Feibel, A. Gi- achino, P. Thurston, P. Rasuli, S. Cartier, H. Hrushowry, W.

Castle, K. Nemeth, C. Carruthers, A. Alton, V. Agarwala; D.

Puskas,* T. Wilson, T. Boudreau, J. Jones, P. Clark, C. Culli- nan, R. VonRichel, S. Stoger; F. Abuzgaya,* H. BenFayed, S.

Gallay, M. Hahn, J. Hummel, E. Sue-A-Quan, B. Woolford, E.

Urovitz, P. Thompson, J. Lichtfuss, R. Kaminker, M. Prieditis, R. Luba, M. Zwicker, R. Firsoff; S.W. Bartol,* D. Danciulescu, S. Danciulescu, D. Fleming, G. Koppert, R. Yovanovich, G.

Annisette, J. Pepin, P. Reynolds, G. Jasey, N. Romanello, W.

Ramsewak, P. Tadros; M. Bent,* R.M. Brock, E.J. Rumble, M.

West, E.C. Orsini, D. Dejewski, H. Dief; G.A. Crawford*, J.P.

Delaney, A. Casses, R. Velazquez, B. Pressnail, S. Styling, W.L.

Robinson, P. Voorheis; L. Flores,* C.M. Offierski, J. Ostrowski,

D. Zaniol, D.L. Mallette, T. Li, R. Dan, H.C. Li, D.B. Lee; R.G.

Josefcheck,* P.F. Robert, D.C. Martin, J.M. Aubin, M. Orshin- sky, D. Nazar, G.C.F. Cook, M.J. Kalchman, R. Rawson; M.

Kliman,* M. Roscoe, G. Vincent, M. Wood, A.E. Maraghy, M.

Mehta, J. Sinclair, M.E. Rick Zarnett,* T.K. Chan, J.J. Wilson, J.

Weiss, B. Smith-Mateschitz, G. Paul Taruli, D. Danciulescu, Shefania Danciulescu; C. Watson*, G. Soon-Shiong, N. Wolf- son, K.J. Mac Con, D. Nemtean, D.H. Pham; V.B. Sennik*, D.

Simmonds, J. Stewart, R. Saplys, N. Clements, D. Wilson, H.

Cheah, D. Davidson, H. Hink, A. Ahmed, T. Stokes; M.

Crowther,* J. Douketis, J. Dobranowski; J. Allen,* J.R. Turn- bull, S.J. Kearney, M. Yee; P. Ansari,* J.Y. Song, B. Rittenhouse, R.M. Aggarwal, S. Demers, E. Nesbitt, S.R. Orsini; A. Chris,*

T. Hupel, J. Israel, P. Schuringa, D. Stevens, P. Stevenson, K.

Tilma, C. McCoy, N. Shenouda; M.J. Kovacs,* S. MacDonald, R. McCalden, C.H. Rorabeck, R.B. Bourne, P. Kudo, M. Rob- bins, C. Talbot, R. Harris, D. Peck; E. Dessouki,* A. Ali, A.

Clark, A.S. Ibrahim, M.G. Martin, C. Osinga, A. Myers, C.

McCallum, H. Lang, L.M. Ames; J. Cisa,* E.J. Robinson, S. Tu- bin, D. Healey, R. Greco, C. Cunningham, L. Forestell, D.

Kelly, N. Beaudry, R. Desjardins; G. Jaroszynski,* M. Suther- land, J. Thomson; Prince Edward Island — A.W. Profitt,* B.E.

Ling, B. Grant, J. Goodwin; Quebec — C. Demers,* C. Petit- clerc, G. Cantin, P.F. Leblond, J. Lyonnais, R. Delage, C. Doyle, J.-M. Turcotte; L. Desjardins,* A. Milot, P. Langis; Israel — D.

Robinson,* R. Avisar, A. Elbaz, A. Oron, A. Peer, A. Altschuler;

M. Roffman,* A. Eyal, M. Aharon, M. Zaidman; Mexico — F.A. Rico,* J.G. Díaz, B.R. Marín, P.J. Elguero, C.A. Rubio;

G.E.M. Reyes,* R.E. García, V.R.F. Castellanos, L.E.M.

Pedroza, J.L.C. Arellano; J.M.M. Camacho,* J.M.J. Avila, S.B.P. Gonzalez, I.L.V. García, J.R. Avila, A.M. Pimentel, V.M.M. Ruelas; J.J.P. Correa,* F.J.M.M. Delgado, I.R. Galvan, J.A.P. Paniagua, I.G. Mendoza, H.Y. Simon, M.C. Villasana;

E.G. Sanchez,* L.N. Rodriguez, E.R. Contreras, F.H. Shoji, R.C. Jimenez, A.C.O. Vallin, D.E.O. Martinez, J.M.H. Campos, J.G. Perez, S.B.P. Gonzalez; S.R. Boschert,* R.C.B. Valladares, J.M. Vargas, J.I.B. Acata; A.D. Fernández,* G.D.R. Argomedo, R.Q. Moreno, L.O.L. Montoya; Brazil — A. Hernandez,* G.T.

Sguizzatto, R. Fecuri, Jr,. I. Momiy, H.K. Iri, C.A. de Souza;

J.B. de Miranda,* I.H. Barcellos, W.E. de Brito, N.S. Yamada, G.A. Alves, L.M. Ceravollo; M. Moreira,* T.Y. Neto, M.L. Si- monetto, A. Moreira, R.P. Buainaim, M.A. de Oliveira Sales, H.K. Farahat, C. de Farias Almeida Alves; M.A.P. de Andrade,*

J.P.K. Matushita, W. Lemos, D.P.B. de Sousa, R.B. de Carvalho de Costa, L.H. Vilela, B.P.C. Fontes, R.L.C. de Resende; N.

Severino,* O.P.A. de Camargo, R. Fecuri, Jr., L.S. Razaboni, N.

Toledo; C.R. Schwartsman,* I. Schmiedt, G.K. de Oliveira, G.L.S. de Freitas, D.P. Tarasconi, A. da Silva Padilha, A.C.

Maciel, A.M.F. Garcia, A. da Silva Padil ha; J.F.A. Pozzi,*

P.C.G. Prestes, S.C. da Costa, L. Zamprogna; S. Mainine,*

P.C.Z. de Faria, R.G. Mombach, A.M.C. Valadao de Freitas, F.V. Carvalho, F.C. Barcelos, E.K. Murata, C.J. Shimizu, C.

Fumo, C.V.F. Kudo, R. do Nascimento Barbosa; G. de Andrade Souza,* M.A. Ribeiro, A. Neser, F. Nasser, S.K. Gertner, M.H. Matsumoto, J.C.S. Simabukuro; C. Milani,* E.K. Mu- rata, S.D. Squassoni.

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TABLE E-I Surgical Details of the Efficacy Population